Meta-analysis of outcomes from drug-eluting stent implantation in femoropopliteal arteries

Objective In recent years, studies of drug-eluting stent (DES) for femoropopliteal artery diseases (FPADs) have been gradually published. To explore whether this type of stent is superior to the traditional bare metal stent (BMS), we performed this study. Methods A systematic search for randomized controlled trials (RCTs) in Excerpta Medica Database (Embase), PubMed, Web of Science (WOS), and Cochrane Library was performed on November 29, 2022. We innovatively adopted the hazard ratio (HR), the most appropriate indicator, as a measure of the outcomes that fall under the category of time-to-event data. The HRs was extracted directly or indirectly. Then, the meta-analyses using random effects model were performed. The bias risks of included papers were assessed by the Cochrane Risk of Bias 2.0 tool. This study was registered on the PROSPER platform (CRD42023391944) and not funded. Results Seven RCTs involving 1,889 participants were found. After pooled analyses, we obtained results without propensity on each of the following 3 outcomes of interest: in-stent restenosis (ISR) -free survival, primary patency (PP) survival, and target lesion revascularization (TLR) -free survival (P >0.05, respectively). Because the results of pooled analyses of the other two outcomes of interest (all-cause death free survival and clinical benefit survival) had high heterogeneity both, they were not accepted by us. Conclusion For FPADs, the DES has not yet demonstrated superiority or inferiority to BMS, in the ability to maintain PP, avoid ISR and TLR.


5-2
Study risk of bias assessment 11 Specify the methods used to assess risk of bias in the included studies, including details of the tool(s) used, how many reviewers assessed each study and whether they worked independently, and if applicable, details of automation tools used in the process.
Effect measures 12 Specify for each outcome the effect measure(s) (e.g.risk ratio, mean difference) used in the synthesis or presentation of results.

Synthesis methods 13a
Describe the processes used to decide which studies were eligible for each synthesis.
13b Describe any methods required to prepare the data for presentation or synthesis, such as handling of missing summary statistics, or data conversions.
13c Describe any methods used to tabulate or visually display results of individual studies and syntheses.
13d Describe any methods used to synthesize results and provide a rationale for the choice(s).If meta-analysis was performed, describe the model(s), method(s) to identify the presence and extent of statistical heterogeneity, and software package(s) used.
13e Describe any methods used to explore possible causes of heterogeneity among study results.
13f Describe any sensitivity analyses conducted to assess robustness of the synthesized results.
Reporting bias assessment 14 Describe any methods used to assess risk of bias due to missing results in a synthesis (arising from reporting biases).

Certainty assessment 15
Describe any methods used to assess certainty (or confidence) in the body of evidence for an outcome.

Study selection 16a
Describe the results of the search and selection process, from the number of records identified in the search to the number of studies included in the review, ideally using a flow diagram.
16b Cite studies that met many but not all inclusion criteria ('near-misses') and explain why they were excluded.

Study characteristics 17
Cite each included study and present its characteristics.

Risk of bias in studies 18
Present assessments of risk of bias for each included study.

Results of individual studies 19
For all outcomes, present, for each study: (a) summary statistics for each group (where appropriate) and (b) an effect estimate and its precision (e.g.confidence/credible interval), ideally using structured tables or plots.

Eligibility criteria 3
Specify the inclusion and exclusion criteria for the review.
Information sources 4 Specify the information sources (e.g.databases, registers) used to identify studies and the date when each was last searched.

Risk of bias 5
Specify the methods used to assess risk of bias in the included studies.

6
Specify the methods used to present and synthesize results.

Included studies 7
Give the total number of included studies and participants and summarise relevant characteristics of studies.

8
Present results for main outcomes, preferably indicating the number of included studies and participants for each.
If meta-analysis was done, report the summary estimate and confidence/credible interval.If comparing groups, indicate the direction of the effect (i.e. which group is favoured).

DISCUSSION
Limitations of evidence 9 Provide a brief summary of the limitations of the evidence included in the review (e.g.study risk of bias, inconsistency and imprecision).
Interpretation 10 Provide a general interpretation of the results and important implications.

Table 2
PRISMA 2020 for Abstracts checklist